WO 2005/026123, which is incorporated herein by reference in its entirety, teaches a class of neutrophil elastase inhibitors that are useful in therapy.
WO 2005/026123 further discloses a specific neutrophil elastase inhibitor compound identified therein as 6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-N-{[5-(methylsulfonyl)pyridin-2-yl]methyl}-2-oxo-1-[3-(trifluoromethyl)phenyl]-1,2-dihydropyridine-3-carboxamide (Example 94, page 85). This compound is designated herein as compound (I).

WO 2005/026123 further discloses a process for the preparation of compound (I).
Thus, in one embodiment of WO 2005/026123, compound (I) is prepared by the route shown in Scheme 1:

The obtained compound (I) was purified by preparative HPLC and freeze-dried to give the free base as a white solid. No specific salts nor any crystalline forms of compound (I) are disclosed in WO 2005/026123.
Compound (I) is a potent neutrophil elastase inhibitor and as such is useful in therapy.
However, compound (I) as the free base is poorly soluble and predictions indicated that the compound (administered as the free base) would demonstrate solubility limited absorption at high doses (for example doses greater than approximately 10 to 20 mg).
In order to prepare pharmaceutical formulations containing compound (I) as the active ingredient for administration to humans there is a need to produce compound (I) in a stable and more soluble form, such as a stable crystalline form, having consistent solid state physical properties which allow pharmaceutical processing.
There is thus a need to find way(s) to enable the poorly soluble pharmacologically active compound (I) to be absorbed to a sufficient degree within such a time frame following oral administration that the concentration of the active compound (I) in the biological fluid(s) is sufficient to get a desired pharmacological effect over a period of time.
The present invention provides a novel salt of compound (I) and a stable crystalline form of such a salt that has consistent and advantageous physical properties. Furthermore, as an additional independent feature the present invention also provides a formulation making it possible for the pharmacologically active compound (I) to be absorbed to the desired degree.